A new diagnostic kit, ODK-1201, for the quantitation of low major BCR-ABL mRNA level in chronic myeloid leukemia: correlation of quantitation with major BCR-ABL mRNA kits

被引：18

作者：

Nakamae, Hirohisa ^{[1
]}

Yoshida, Chikashi ^{[2
]}

Miyata, Yasuhiko ^{[3
]}

Hidaka, Michihiro ^{[4
]}

Uike, Naokuni ^{[5
]}

Koga, Daisuke ^{[6
]}

Sogabe, Takayuki ^{[6
]}

Matsumura, Itaru ^{[7
]}

Kanakura, Yuzuru ^{[8
]}

Naoe, Tomoki ^{[9
]}

机构：

[1] Osaka City Univ, Grad Sch Med, Hematol, Abeno Ku, Osaka 5458585, Japan

[2] Mito Med Ctr, Natl Hosp Org, Dept Hematol, Ibaraki, Japan

[3] Nagoya Med Ctr, Natl Hosp Org, Hematol, Nagoya, Aichi, Japan

[4] Kumamoto Med Ctr, Natl Hosp Org, Hematol, Kumamoto, Japan

[5] Kyushu Canc Ctr, Natl Hosp Org, Hematol, Fukuoka, Japan

[6] Otsuka Pharmaceut Co Ltd, Div Diagnost, Tokushima 77101, Japan

[7] Kinki Univ, Sch Med, Dept Internal Med, Hematol, Osaka, Japan

[8] Osaka Univ, Grad Sch Med, Hematol & Oncol, Osaka, Japan

[9] Nagoya Med Ctr, Natl Hosp Org, Nagoya, Aichi, Japan

来源：

INTERNATIONAL JOURNAL OF HEMATOLOGY | 2015年 / 102卷 / 03期

关键词：

CML; RT-qPCR; Major BCR-ABL mRNA; ODK-1201; CHRONIC MYELOGENOUS LEUKEMIA; TYROSINE KINASE INHIBITORS; CHRONIC-PHASE; EUROPEAN-LEUKEMIANET; IMATINIB; DASATINIB; RECOMMENDATIONS; NILOTINIB; THERAPY; CML;

D O I：

10.1007/s12185-015-1826-9

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

The current first-line therapy of chronic myeloid leukemia (CML) is based on tyrosine kinase inhibitors. Diagnostic kits that are capable of identifying at least a 4.5 log reduction in the international scale % BCR-ABL/ABL (IS % BCR-ABL/ABL) are needed for use in the clinical evaluation of deeper molecular response to treatment and to determine the timing of dose selection or treatment interruption during the course of treatment. In this study, we evaluated the performance of a new diagnostic kit, ODK-1201, designed to be capable of performing reverse transcription and quantitative PCR in a single tube for the quantitation of major BCR-ABL mRNA. The kit demonstrated excellent assay performance (limit of detection 0.0007 %) and a broader detection range of BCR-ABL mRNA in peripheral blood compared to a commercially available kit for CML (Amp-CML). ODK-1201 was also shown to be as sensitive as Ipsogen and Molecular MD kits in the same assay. Results obtained in this study indicate evidences that ODK-1201 was capable of identifying at least a 4.5 log reduction in the IS % BCR-ABL/ABL.

引用

页码：304 / 311

页数：8

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